PVC Hydrophilic Urethral Catheter
The PVC Hydrophilic Urethral Catheter is a single-use catheter for intermittent bladder drainage through the urethra. Its medical-grade PVC shaft has a polyvinylpyrrolidone coating that…
The PVC Hydrophilic Urethral Catheter is a single-use catheter for intermittent bladder drainage through the urethra. Its medical-grade PVC shaft has a polyvinylpyrrolidone coating that binds water to form a lubricated surface.
Water activates the coating before insertion. Configurations are supplied with or without a water sachet, and wetting the catheter for the specified preparation period makes the coating slippery.
Listed Item
Bending head water sachet type,Catheter OD.14Fr
Catheter Options
The family includes male and female configurations in sizes from 8 to 18 Fr. Water-sachet versions supply the activation water in the pack; other versions use purified water. The hydrophilic layer reduces friction between the catheter surface and urethra during insertion.
Who Else Makes It
Concentrated in Jiangsu (9), Zhejiang (7), Shanghai (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Haiyan Kangyuan Medical Instrument Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Shaoxing Fuqing Health Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 3 |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 3 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
Showing 12 of 21. All 21 manufacturers in China registered for Catheter, Straight
Record
| Listed by | Chengdu Daxan Innovative Medical Tech. Co., Ltd., China |
|---|---|
| FDA product code | EZD |
| Device type | Catheter, Straight |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Manufacturer |
| 510(k) | K212567 |
| Record published | 2023-09-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H01-18M | 30 | In distribution | |
| H01-16MS | 30 | In distribution | |
| H01-08MS | 30 | In distribution | |
| H01-14WS | 30 | In distribution | |
| H01-10FS | 30 | In distribution | |
| H01-10WS | 30 | In distribution | |
| H01-14MS | 30 | In distribution | |
| H01-10W | 30 | In distribution | |
| H01-12WS | 30 | In distribution | |
| H01-12M | 30 | In distribution | |
| H01-10M | 30 | In distribution | |
| H01-12FS | 30 | In distribution | |
| H01-18FS | 30 | In distribution | |
| H01-14M | 30 | In distribution | |
| H01-08M | 30 | In distribution | |
| H01-12F | 30 | In distribution | |
| H01-16WS | 30 | In distribution | |
| H01-16FS | 30 | In distribution | |
| H01-12W | 30 | In distribution | |
| H01-10MS | 30 | In distribution | |
| H01-16M | 30 | In distribution | |
| H01-10F | 30 | In distribution | |
| H01-18F | 30 | In distribution | |
| H01-16W | 30 | In distribution | |
| H01-14W | 30 | In distribution | |
| H01-08F | 30 | In distribution | |
| H01-16F | 30 | In distribution | |
| H01-12MS | 30 | In distribution | |
| H01-14FS | 30 | In distribution | |
| H01-14F | 30 | In distribution | |
| H01-08FS | 30 | In distribution | |
| H01-18MS | 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable intermittent catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 140 |
| LoFric® Hydro-Kit™ | Wellspect Healthcare | 57 |
| LoFric® | Wellspect Healthcare | 56 |
| SimPro™ Now | Wellspect Healthcare | 55 |
| Self-Cath | Coloplast A/S | 50 |
| Wellead PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 50 |
| LoFric® Primo™ | Wellspect Healthcare | 48 |
| Medline | Medline Industries, Inc. | 47 |
| Halyard | Owens & Minor Distribution, Inc. | 39 |
| Cure Catheter | Convatec, Purchasing Department | 39 |
| AMSure® PVC Intermittent Catheter | Amsino Medical Inc. | 39 |
| LoFric® Origo™ | Wellspect Healthcare | 34 |
Showing 12 of 72. All products under Catheter, Straight
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243175 | 2025-06-26 |
| K212567 | 2022-12-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.